Product Information Specialist
Role details
Job location
Tech stack
Job description
As Production Information Specialist, you will be responsible for creating, maintaining, and ensuring the accuracy of product information and labelling for the genetics product group. This role ensures that all labelling and product information comply with global regulatory requirements and internal quality standards to support the safe and effective use of Vitrolife Group products and services. You'll collaborate across departments to ensure that production information is accurate, accessible, and aligned with regulatory and international standards. You'll thrive in a fast-paced, collaborative environment alongside highly skilled and dedicated colleagues. Whether maintaining master labelling records or supporting digital transformation, your attention to detail and cross-functional communication will be essential. This role focuses on ensuring our processes are supported by robust documentation and data systems throughout the product lifecycle - from production planning through post-market support - in close coordination with our Quality Assurance and Regulatory Affairs teams., * Compliance Support: Ensure all labelling materials comply with applicable international regulations (e.g., IVDR, FDA 21 CFR Part 809, CLIA and ISO standards). Collaborate with regulatory affairs to interpret and implement labelling requirements.
- Documentation Oversight: Create, update, review product labels and instructions for use (IFUs) for IVD products. Review and update test requisition forms (TRFs) and test reports for LDT portfolio. Ensure accurate and consistent translation of labelling content for international markets. Manage document version control and maintain labelling archives.
- Cross-functional Collaboration: Work closely with R&D, Quality Assurance, Regulatory Affairs, Marketing, Manufacturing and Lap Operations teams to gather and validate content. Participate in cross-functional labelling change control processes and product launches.
- Process Optimization: Analyze data to identify trends and opportunities for efficiency and quality improvements. Identify and implement process improvements to labelling workflows and documentation practices.
- Content Quality and Accuracy: Proofread and verify technical content, specifications, warnings, and instructions in product information. Ensure readability and usability of information for end-users and customers.
Requirements
Do you have experience in Usability?, Do you have a Master's degree?, * Hold a Bachelor's or Master's degree in biology, chemistry, physics, or equivalent or experience of regulatory affairs for ART.
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Bring 2-5 years of experience in production documentation, manufacturing operations, or data systems within the IVD or medical device industry.
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Knowledge of lab-developed tests (LDTs), IVD regulations, and ISO 13485 standards is highly desirable.
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Systematic and analytical, yet proactive and pragmatic in finding solutions within a dynamic environment.
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Detail-oriented, decisive, and a true team player, who builds strong relationships.
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Curious and passionate about production systems and continuous improvement.
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Fluent in both Spanish and English.
Preferred Skills
- RAC (Regulatory Affairs Certification) is a plus.
- Understanding of IVD/LDT production workflows and documentation requirements.
Benefits & conditions
- Be part of a mission-driven team improving patient outcomes through innovative diagnostics.
- Work in a collaborative, fast-paced environment with opportunities for growth.
- Enjoy a competitive salary, benefits, and support for ongoing professional development.
Apply today We're eager to fill this position and will conduct interviews on a rolling basis until the right candidate is found. We look forward to hearing from you!
